Immuno - inflammatory diseases therapy
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Aclaris Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-06 11:59
Core Insights - Aclaris Therapeutics reported positive results from the Phase 2a trial of its ITK/JAK3 inhibitor ATI-2138, confirming ITK as a therapeutic target and planning to initiate a Phase 2 trial in additional indications in the first half of 2026 [1][3] - The company has a strong cash runway expected to fund operations into the second half of 2028, with potential for further non-dilutive financing opportunities [2][10] - Aclaris is advancing a diversified pipeline targeting immuno-inflammatory disorders, with significant clinical milestones anticipated throughout 2026 and 2027 [2][3] Pipeline Developments - The Phase 2a trial of ATI-2138 achieved primary and key secondary endpoints, showing a 77% decrease in Eczema Area and Severity Index (EASI) score and a 64% reduction in Body Surface Area (BSA) score at week 4 [3] - Aclaris plans to file an Investigational New Drug (IND) application for a next-generation JAK-sparing ITK inhibitor in the second half of 2026 [3] - The company expects to initiate Phase 1b proof-of-concept trials for ATI-052 in asthma and atopic dermatitis in the first half of 2026 [1][10] Financial Performance - As of September 30, 2025, Aclaris had cash, cash equivalents, and marketable securities totaling $167.2 million, down from $203.9 million at the end of 2024 [6][20] - The net loss for the third quarter of 2025 was $14.6 million, compared to $7.6 million for the same period in 2024, with a total revenue of $3.3 million, down from $4.3 million year-over-year [7][8] - Research and development expenses increased to $13.0 million for the third quarter of 2025, driven by costs associated with clinical development and product candidate manufacturing [9][11]